[Recalled] Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. — If the inflow speed is too quick, it could result in reduced outflow through th… | FDA 2024-11-27
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. |
|---|---|
| Brand / manufacturer | Trokamed GmbH |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0714-2025 |
| Country of notice | Germany |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 27 November 2024 |
| EAN / barcode | 04251303810919 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
This Class I recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from Trokamed GmbH
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.